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Sign in to claim this brandDRGEM Corporation
South Korea·KR-MF-000017990
Last updated September 17, 2026
Information
- Country
- South Korea
- Address
- 60, Haan-ro, Gwangmyeong, South Korea
- Website
- www.drgemhealthcare.com
- —
- —
- [email protected]
- Phone
- +82 70 8230 8561
- PRRC Contact
- Sung-hee Park
- EUDAMED SRN
- KR-MF-000017990
- FDA FEI Number
- 3006551157
- DUNS Number
- 688477319
Catalogue (377)
Page 8 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Drgem | SGXR-68SD | FDA UDI | Class II | Active |
| Drgem | SGXR-68S | FDA UDI | Class II | Active |
| Drgem | SGXR-C52S | FDA UDI | Class II | Active |
| Drgem | GXR-EC25 | FDA UDI | Class I | Active |
| Drgem | SGXR-U40SD | FDA UDI | Class II | Active |
| Drgem | SGXR-40SD | FDA UDI | Class II | Active |
| FDR Clinica | FDR Clinica FGXR-82S | FDA UDI | Class II | Active |
| Drgem | GXR-52S | EUDAMEDFDA UDI | Class II | Active |
| Drgem | FDR Smart FGXR-32S | FDA UDI | Class II | Active |
| FDR Clinica | FDR Clinica FGXR-68S | FDA UDI | Class II | Active |
| FDR Clinica | FDR Clinica FGXR-C32S | FDA UDI | Class II | Active |
| FDR Clinica | FDR Clinica FGXR-40S | FDA UDI | Class II | Active |
| Topaz Mobile DR System | K183292 | FDA 510(k) | Class II | Active |
| Diamond-5a/6a/8a | K192453 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| RADMAX Digital Imaging Software | K182537 | FDA 510(k) | Class II | Active |
| GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) | K232178 | FDA 510(k) | Class II | Active |
| Promo | K251443 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| JADE Mobile X-Ray | K183388 | FDA 510(k) | Class II | Active |
| GXR-Series Diagnostic X-Ray System | K192364 | FDA 510(k) | Class II | Active |
| TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | K242015 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| GXR-Series Diagnostic X-Ray System | K242019 | FDA 510(k) | Class II | Active |
| GXR-Series Diagnostic X-Ray System | K202572 | FDA 510(k) | Class II | Active |
| Digital Diagnostic X-Ray System | K102408 | FDA 510(k) | Class II | Active |
| Diamond-5a/6a/8a | K202156 | FDA 510(k) | Class II | Active |
| TOPAZ Mobile DR System | K201124 | FDA 510(k) | Class II | Active |
| Radiological PACS Software | GEMPACS | EUDAMEDFDA UDI | Class I | Active |
| Digital Imaging System | ACQUIDR | EUDAMED | Class IIa | Active |
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